FDA 510(k)

Nihon Kohden NKV-330 Ventilator System

K号: K213521 · 2022-07-01

决定日期2022-07-01

产品代码MNT

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决定实质等同

器械摘要

Nihon Kohden NKV-330 Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Orangemed, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213521. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nihon Kohden NKV-330 Ventilator System?

Nihon Kohden NKV-330 Ventilator System is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Nihon Kohden Orangemed, Inc.. The 510(k) number is K213521.

When did Nihon Kohden NKV-330 Ventilator System receive FDA 510(k) clearance?

Nihon Kohden NKV-330 Ventilator System received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213521.

Who is the listed applicant for Nihon Kohden NKV-330 Ventilator System?

The FDA 510(k) record lists Nihon Kohden Orangemed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nihon Kohden NKV-330 Ventilator System?

The FDA product code for Nihon Kohden NKV-330 Ventilator System is MNT.

列明Nihon Kohden Orangemed, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222644日立医電 NKV-440 呼吸机系统 K192307日立医電 NKV-550 系列呼吸机系统 K181695日立医電 NKV-550 系列呼吸机系统

官方来源

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